Most obstetricians and nurse-midwives recommend that the first prenatal medical appointment for a pregnant woman be scheduled as early as possible in the pregnancy. Typically, subsequent prenatal visits initially occur at one-month intervals, then twice a month, then weekly in the latter stages of uncomplicated pregnancy. Complicated pregnancies may warrant twenty or more prenatal visits. For many practices of obstetrics-gynecology, prenatal visits constitute the majority of office appointments. Each prenatal visit recurrently utilizes a small collection of obstetrical supplies and instruments.
At each prenatal visit the practitioner attempts to detect, across the surface of the maternal abdominal wall, evidences of fetal cardiac activity. Traditionally this was ascertained by auscultation of fetal heart sounds using a specialized obstetrical stethoscope. Contemporary methods are more rapid and reliable, and typically give the gravid patient the immediate reassurance that her developing baby is alive and well. Of such newer cardiac activity detection methods, sensitive microphones and fetal electrocardiogram recordings have been largely supplanted in today's medical office by the compact, easy-to-use ultrasonic Doppler device. Essentially a medical sonar, it detects Doppler frequency shifts in those returning ultrasonic energy waves which it has reflected off moving components of the fetal cardiovascular system, such as flow of blood in the largest fetal vessels. Such frequency shifts are then converted to an audible signal.
Most commercially available Doppler units are portable, battery-operated devices small enough to be cradled in the palm of the hand. These typically comprise a probe or transducer that is applied to the surface of the maternal abdomen and wired to a separate speaker-containing base unit. When the device is not in use it may be placed in the lab coat pocket of the practitioner, or left on or within storage cabinetry. Some models provide a clip by which the base unit may be attached to the practitioner's pocket edge or belt, and some provide a niche within the base unit, to store the probe.
A hand-held fetal Doppler is an expensive medical device. It is fragile, small enough to be easily concealed, and fascinates the patient and her family with its function: they are able by means of it to hear sounds made, albeit indirectly, by the baby. To a young child accompanying its mother into the examination room, the device may resemble a toy. Perhaps because of its capabilities and natural appeal, dropping, tampering and theft are the chief reasons for Doppler repair or replacement. Therefore the hand-held Doppler, while it must be easily accessible to medical personnel, needs protection from unauthorized handling. This might involve fixing the Doppler to a protective base, integrating the Doppler function into a multifunctional piece of equipment too large to be concealed, and/or fashioning an alarm system triggered by tampering.
Practical advances in hand-held Doppler design generally comprise elimination of the wire or cord between the Doppler probe and base unit, digital display of the fetal heart rate, and multiple probes for a single base unit.
Doppler devices minus the wire or cord avoid the annoyances of entanglement, twisting, or inappropriate wire length that can interfere with Doppler use. One such design integrates a transmitter into the Doppler probe. It sends an RF or infrared signal to a remote base unit where a circuit converts the signal into a sound. Another design simply integrates speaker and probe into a single hand-held housing. Accordingly, the present invention accommodates such variations in Doppler design, and additionally provides mechanisms for theft and tampering protection for Doppler models with either one or two portable housings.
Models which numerically display fetal heart rate obviate the need for the practitioner to count the fetal signal over a short time span and then mentally convert the data to beats per minute. However, the base unit must be positioned by the present invention so that the practitioner can easily read the fetal heart rate display.
Doppler models with more than one probe allow the practitioner to select the frequency range of ultrasonic wave detection that is most appropriate for the particular gestational age of the fetus. This enables, for example, Doppler detection of fetal life earlier in pregnancy or in obese patients. Protected storage of a readily accessible standby probe is therefore preferable, and is not provided by the prior art.
As with Doppler, sonography (ultrasound scanning) involves the painless application of a small hand-held device, the sonogram scanhead, upon a body surface, in this case the maternal abdominal or vaginal wall, enhanced by ultrasound conduction gel applied at the interface. This technology converts the reflected ultrasonic energy waves into cross-sectional fixed or moving images of the targeted internal wave-reflecting structures. Laypersons and professionals alike regard it as the chief diagnostic technique for many obstetric situations. Its understandable, instantaneous images enable the skilled medical professional to demonstrate findings to the patient as her scan progresses. Such participation of the patient demystifies the obstetric complication and often communicates the rationale for the medical recommendations which follow.
Not uncommonly at a routine prenatal visit a practitioner must broach the disturbing possibility of an obstetric problem amenable to ultrasound study. A sonogram offered immediately, not scheduled for some more convenient day, minimizes the patient's understandable tension and suspense and allows prompt redirection of medical management. Unfortunately, however, the scanning equipment often lies idle and inaccessible in an examination room then occupied by another patient. Scan capability in each exam room should instead permit an immediate sonogram with minimal disruption of office function.
While sonography should hardly be offered primarily to entertain, it is immensely popular with patients and it lacks known medical risk. Because it can reveal the undeniably humanoid image and heart motions of the fetus several weeks before the hand-held Doppler can demonstrate fetal life, sonography can foster that earlier parent-to-child and parent-to-parent bonding and commitment which invariably strengthen the family unit and promote a desire to nurture the pre-born child. Sensing this, even couples with apparently uncomplicated pregnancies desire and benefit from a sonogram.
Whether because of client expectations or the weight of proven medical benefit, ready availability of scan equipment in each obstetrical exam room is highly desirable. While someday sonography may supplant Doppler fetal heart detection at the routine prenatal visit, today the low portability and high cost of scanning equipment restricts any-visit sonography to the offices of perinatologists and a very few generalist obstetricians. The practical need for hand-portable, sophisticated yet cost-effective obstetric sonography equipment remains unmet. Miniaturization of already costly sonography devices may render them too expensive for the office. Situating a complete conventional scanning unit in each exam room, likewise unaffordable (such computer-based devices suffer rapid obsolescence), additionally encourages tampering with the unattended equipment.
The conventional sonogram scanhead itself is as compact as is a hand-held Doppler. Its attached two-meter computer style electronic cable with multi-pin connector yields this scanhead assembly somewhat more awkward than a hand-held Doppler to transport. Yet if it were possible to scan a patient in any exam room by carrying a single scanhead assembly room to room, each time recruiting the function of a single remotely placed signal processing console, portability might be achieved without costly miniaturization. The current invention accomplishes a portability system by which such a scanhead assembly could be easily and securely carried from room to room.
There are several design preferences for such a portability system. The scanhead assembly of most commercial sonogram devices is preferably accommodated within a portable housing which protects it, and allows for its convenient use and transfer. The practitioner should find it convenient to accurately engage and gently disengage the pin-socket arrays of the necessary electrical connectors. The system should provide dedicated routes for the electronic cables that connect scanhead to central processing console. At each scanning location, the position of the scanhead-bearing portable housing should not compromise the excursion of the scanhead to any body site typically scanned during pregnancy.
The present invention furthers the quest for portable office sonography. Design and installation of sonography equipment to be used with the present invention may be based on and/or coordinated with the design of the invention as discussed hereinbelow. Such accommodation is contemplated by and intended to be within the scope of the invention. In particular, manufacturers of sonography equipment will need to provide control of basic console functions at each examination table, and to properly amplify signals from the scanhead so these can traverse an increased distance to the console. Installers will need to provide each scan site with a well-positioned viewing screen connected to the processing console. Electronic privacy will need to be assured by a switching mechanism whereby the processing console attends signals only from, and returns data only to, the site of the scan.
Expectant couples often seek to remember their prenatal experiences by documenting the ongoing life and progress of the developing fetus. For example, some patients bring a tape recorder and ask permission to record the Doppler sounds caused by fetal heart activity. Other patients request keepsake photographs or videotapes of some of the sonogram images of their fetuses. The current invention enhances patients' appreciation of a particular obstetric practice by fulfilling such desires. With minimal investment of time and attention from medical personnel, the patient herself may document the life and activity of her own fetus.
There are a number of other obstetrical, gynecologic, vascular surgical, or other medical instruments and supplies commonly used alongside Doppler or sonography equipment. These may include a container of ultrasonic conduction gel to enhance transmission of Doppler or sonogram signals across human body surfaces; a supply of tissue for wiping used ultrasonic gel from Doppler probe, ultrasound scanhead, or the patient; a discard basin for such tissue or other spent disposable items; a container of lubricating gel to enhance patient comfort during internal digital examinations; measuring tape in a retractable reel for determining uterine growth and size; a roll of pH-sensitive phenaphthazine ("nitrazine") test paper to determine whether rupture of the amniotic membranes has occurred; a due-date calculator wheel; a reflex hammer for evaluation of hypertensive conditions in and out of pregnancy; a penlight for close inspection of nail beds, pupils, or skin lesions; a writing instrument; a prescription pad; a pad of adhesive writing papers; and the patient's medical chart.
When these items are not in use, such as between two successive obstetric appointments in an office day, it is typical practice for various of these items (as in the case of the Doppler) to be stored in the pockets of the practitioner's lab coat, individually hand-carried, or left in or on cabinetry inside or outside the examination room. Moreover, nowadays many practitioners have dispensed with the wearing of laboratory coats with their storage pockets. Therefore obstetric instruments may have been strewn in locations inconvenient or unknown to the practitioner, who must either pause to personally retrieve these, or send his office assistant on a similar errand. Such unnecessary distractions waste office time, annoy assistants, and make the practitioner appear implement-oriented. They tend to deprive patient and caregiver of the satisfactions of a successful prenatal visit wherein the caregiver should have been enabled to focus fully on the patient and deal effectively with her concerns. Worse, the distracted or annoyed practitioner is prone to overlook some important detail of the patient's medical situation and commit a serious medical blunder.
A device or system for organizing obstetric implements is most useful if it helps the practitioner complete tasks smoothly, with little wasted motion. In each examination room the organizing system should arrange all implements in an unchanging compact array adjacent to practitioner and patient. In fact, attachment of the implement site to the examination table is desirable unless such interferes with operation of the examination table or hinders physical access to the patient.
Another concern of the caring practitioner is the temperature of lubricating and/or ultrasonic transmission gels that he applies from time to time to obstetric patients. Typically, ultrasonic conduction gel for abdominal Doppler or sonography is squeezed from a plastic container directly onto the bare abdomen of the patient. Direct skin application of this water-based gel, even at room temperature, causes a mildly jarring sensation akin to dripping cold water onto the body. Such discomfort is more notable during winter months when, due to the slight lowering of ambient office temperature, the temperature gradient between skin and gel increases, Similarly, non-heated lubricating gel applied directly to the patient's genitalia for a digital cervical exam adds the elements of surprise and discomfort to an experience which, for other reasons, the patient already expects to dislike. In any case, use of these substances at room temperature is inconsistent with the soothing environment which practitioners desire to create.
A known tactic is to warm such gel prior to direct skin application. A few practices employ freestanding countertop gel heaters in each examination room near an electrical outlet, not necessarily near the patient. Among currently available warmers, temperature set-point options are typically limited or absent, and no known model displays current gel temperature. The practical value of these existing models is therefore limited by paucity of gel temperature options, by cost (because convenience requires one in each exam room), and typically by remoteness of the gel heating site from the point of use. Some practitioners even resort to the quite unpredictable heating of gel bottles upon a conventional heating pad lining the bottom of a nearby cabinetry drawer.
There are prior art containers that are designed for heating medical products. U.S. Pat. No. 4,523,078 issued to Lehmann discloses a portable electrically heated container for transporting infusions. The container is shaped like a suitcase with a thermally insulated outer section and a heating element positioned inside the insulated portion. U.S. Pat. No. 5,183,994 issued to Bowles discloses a heated drug box that has a main compartment and a side compartment that is in thermal contact with a heater which can be connected to a power source and regulated by a temperature control. The side compartment is adapted for storage of intravenous solutions and is accessible without otherwise opening the drug box to the environment.
A significant number of obstetric patients develop blood pressure abnormalities which must be accurately monitored. Typically, the most reliable readings are obtained from patients lying supine or upon their left side. In the typical medical office, the obvious choice of furniture for such positioning is the examination table. The accuracy of blood pressure readings is further improved if the measuring device is positioned at the approximate height of the patient's body upon the examination table. An apparatus that allows positioning the blood pressure measuring device at approximately table top height adjacent the examination table would permit practitioners to more accurately monitor the patient's blood pressure.
Accordingly, what is needed and what is not found in the prior art is an apparatus for organizing, transporting, and facilitating the use of obstetrical and other medical devices and supplies with the following characteristics:
1. Portability of expensive, delicate, or misusable medical devices and supplies within one housing that may be reversibly and conveniently mounted at each examination site; PA0 2. Compatibility with a wide range of commercially available hand-held Doppler devices, and/or integration of Doppler functions within the apparatus itself; PA0 3. Compatibility with a wide range of commercially available sonogram scanheads and their associated electronic cabling and connectors; PA0 4. Connectability to most conventional examination tables found in offices of obstetrics and gynecology; PA0 5. Functionality from either side of the examination table, and for left- or right-handed practitioner; PA0 6. Noninterference with operation of the examination table; PA0 7. Noninterference with access to the examination of patients; PA0 8. Convenient array of those medical devices and supplies necessary for the typical prenatal visit, without unreasonable duplication of expensive items; PA0 9. Protection and security of medical implements especially vulnerable to unauthorized handling; PA0 10. Accommodation of optional commonly used implements within the array; PA0 11. Provision of adjustable warming of medical gels adjacent to the point of use; PA0 12. Enablement of the patient to document for herself the life and activity of her fetus, with minimal expenditure of time and effort by medical personnel; and PA0 13. Provision for blood pressure determinations when the patient can be positioned optimally for these readings.
An apparatus accomplishing such functions will offer medical personnel a welcome reduction in time, motion, petty frustration, and equipment repair or replacement. By helping medical personnel focus on patients, such apparatus should help to fulfill the fundamental desire of both patient and caregiver that care be provided with competence, efficiency, attentiveness, and warmth.